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Official statement of Philip Morris Moldova to amendment №52 regarding the regulation of heated tobacco products

PMI Official

Executive Summary

Government-industry interactions are legitimate as long as they take place within the framework and limits of Article 5.3 and are accountable and transparent. Article 5.3 does not prohibit government-industry interactions.

In full transparency, and in adherence to the principles of good governance, good regulatory decision-making and better regulation, Philip Morris Moldova, an affiliate of Philip Morris International (PMI), wishes to contribute to the debate on harm reduction and the need to regulate different products, differently.

Not all tobacco products are the same.

Public health experts around the world have concluded that innovative products like heated tobacco and e-cigarettes can play an important role in reducing smoking and the harmaful effects of smoking. But many adult smokers are not aware that such products exist, or don’t understand their benefits compared to cigarette smoking.

Regulation plays a key role in facilitating that adult smokers have access to accurate and non-misleading information about such products to help the adult smokers who do not quit to make a better choice than continue to smoke cigarettes.

Different products should be regulated differently. The most harmful products, cigarettes, should be subject to the most restrictive measures. Smoke-free products, which are less harmful, should be subject to regulation that encourages adult smokers to switch to them and prevent initiation by non-smokers, particularly youth, relapse to nicotine-containing products by former smokers, and long-term dual use.

Several governments around the world (e.g., the United Kingdom, New Zealand, EU, USA) are leading the way by recognizing these new products and regulating them differently than cigarettes, encouraging adult smokers who do not quit to switch to better alternatives.

Moldova also has the opportunity to continue to be a leader in this area and to improve public health by maintaining a differentiated regulatory framework for these innovative products. In its current form, the proposal is a step backwards for the protection of public health in Moldova.

 

 

Introduction

The Republic of Moldova has ratified the WHO Framework Convention for Tobacco Control (FCTC). In line with the FCTC, the Republic of Moldova has committed to respect article 5.3 which provides: “In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law.”

 Article 5.3 does not prohibit government-industry interactions. It implicitly recommends regulators to act in an impartial manner and protect policy making from “commercial and other vested interests of the tobacco industry”.

The subsequent Guidelines for Implementation of Article 5.3 recognize that industry-government interactions will occur and offer further guidance to the Parties on how to fulfil that specific treaty obligation[1]. The core recommendations contained in the Guidelines indicate that Parties can interact with the industry whenever necessary from a policy standpoint, as long as such interactions are accountable and transparent.

Participation in a public hearing related to a concrete law proposal falls squarely within those boundaries, and is by its very nature both transparent and ensures full accountability of the parties involved in the process. In fact, this principle is stated directly in the Guidelines:

Where interactions with the tobacco industry are necessary, Parties should ensure that such interactions are conducted transparently. Whenever possible, interactions should be conducted in public, for example through public hearings, public notice of interactions, disclosure of records of such interactions to the public.[2] (emphasis added)

This is also the position taken by many of the Parties to FCTC in implementing their obligations under Article 5.3. The European Union Commission, for example, has declared that “stakeholder consultations are fully compatible with [Article 5.3] guidelines.”[3]

 

Including tobacco companies in public hearings related to the tobacco control legislation is not only acceptable and compliant with Article 5.3 of the FCTC, it is directly recommended in the Guidelines and at the same time it ensures adherence to the principles of good governance, good regulatory decision-making and better regulation.

On that basis, Philip Morris International welcomes the opportunity to provide its comments on the proposal (referred to as the Proposal) pertaining to the amendment of among others Law no. 278/2007 on tobacco control (referred to as the Tobacco Control Law).

Everyone knows what cigarettes are. They are the most popular tobacco product in Moldova and the rest of the world. Because they burn tobacco, they are also the most harmful. The burning of tobacco is responsible for the production and transfer of the vast majority of toxins that experts agree are the primary cause of smoking-related disease.

Today, a range of scientifically substantiated tobacco and nicotine products, such as e-cigarettes and heated tobacco (or “smoke-free products”), deliver nicotine without burning tobacco with the potential to be less harmful than cigarettes. Many public health experts and several governments agree that these products are much better than continued smoking. If all adult smokers who will not quit would switch completely to these better alternatives, this would dramatically improve their lives and would ultimately lead to the end of cigarette smoking in Moldova.

But to achieve such goal and help the current smoking population to leave cigarettes behind, regulation differentiating smoke-free products from cigarettes is key so that adult smokers are not kept in the dark about these products and are offered the opportunity to switch to a less harmful, smoke-free alternative.

Why cigarettes and smoke-free products should be regulated differently

All tobacco products should be regulated, but not all tobacco products should be regulated in the same way. The most harmful products, cigarettes, should be subject to the most restrictive measures. Smoke-free products, which are less harmful, should be subject to regulation that encourages adult smokers to switch to them and prevent initiation by non-smokers, particularly youth, relapse to nicotine-containing products by former smokers, and long-term dual use. However, it is important not to lose sight of the benefits these products can provide to smokers.

Regulating smoke-free products and cigarettes the same way would actually result in unfair competition in favor of cigarettes as the well-established product. To encourage switching, regulation should ensure that smokers have access the information they need to make better decisions for their health.

In fact, applying cigarette regulation to smoke-free products, can prevent adult smokers from switching and provide de facto protection for cigarettes.[4] As a result, instead of making better choices, many will continue to smoke cigarettes.[5] In effect, over-regulating smoke-free products encourages the use of the most harmful products on the market.[6]

As smoke-free products are a better choice than continued smoking, they should not be regulated the same as cigarettes. An appropriate approach would be risk-proportionate regulation of tobacco and nicotine-containing products. The most harmful products – cigarettes, should be subject to the most restrictive measures. Smoke-free products, which are less harmful, should be subject to regulation that encourages adult smokers to switch to them. To encourage switching, regulation should ensure that adult smokers have access to less harmful products and the information they need to make better choices for their health.

The ability to commercialize to and communicate with adult smokers is critical to raise awareness, understanding, and acceptance of smoke-free products as an alternative to cigarettes. Through commercialization and consumer communications, manufacturers can tell consumers what the product is, how it works, any substantiated product benefits, who the product is for, and most importantly, who it is not for.  Consumer communication is especially important for new and innovative products like e-cigarettes and heated tobacco products, because they are fundamentally different from cigarettes in terms of taste, sensorial experience and functionality. These differences can be significant barriers to trial for smokers unless there are opportunities to clearly explain the products’ attributes and benefits to smokers.

Moreover, if communications about smoke-free products are restricted to the same extent as cigarettes, this is likely to prolong cigarette smoking. The UK Royal College of Physicians has observed:

While it may be tempting to ban e-cigarette advertising by simply extending the prohibition of tobacco advertising, this would be disproportionate and counterproductive. … [I]t would make it harder to communicate innovation, including innovation in health and safety, ease of use and experience relative to smoking. In doing so, it could slow the steady displacement of smoking by vaping.[7]

This same concern recently led a court in Quebec, Canada to strike down certain regulations that restrict communications with adult smokers regarding e-cigarettes, on the grounds that the restrictions were an unconstitutional restriction on freedom of expression. In reaching this conclusion, the court explained:

The problem with the current restrictions is that the public, especially smokers, do not distinguish between smoking and vaping. They must be permitted to know the difference. Rather than silence, it is sometimes necessary to educate and let people know that vaping exists first and foremost for smokers. Federal legislation is more permissive about this and distinguishes the more severe tobacco advertising rules from those on vaping. In Quebec, certain limits are overbroad.[8]

The Quebec court also struck down a ban on product trial at the point of sale, concluding that such a prohibition would deprive smokers of the opportunity to switch to a less harmful product:

[T]he alleged provisions deprive the smokers of an important means of making a successful transition, of eventually quitting and eliminating (or at least reducing) tobacco’s negative effects. It seems important to be able to inform the consumer well, to advise him in the way of doing and to facilitate his task. However, this goal will be more easily achieved if he has the opportunity to try it in the presence of a salesman and specialized advisor. . . In short, by depriving smokers of the possibility of a trial in a shop or clinic, their integrity is compromised because they are denied, in part, better access to a risk-reduction mechanism allowing them to better preserve their health and integrity. [9]

In addition to the channels available for consumer communications about smoke-free products, the content of those communications are an important factor in convincing smokers who do not quit to switch to better alternatives. In particular, the ability to communicate substantiated reduced risk information about different tobacco and nicotine products is critical. If adult smokers properly understand the different risk profiles of various tobacco products, they are more likely to quit smoking, or if they want to continue using nicotine, to switch from cigarettes to less harmful alternatives. Therefore, it makes sense for manufacturers to be allowed and encouraged to communicate factual, scientifically substantiated reduced risk information to consumers. 

Separately, a distinction shall also be made between tobacco products and devices for heating tobacco, which are not derived from tobacco, do not contain tobacco in whole or in part, cannot be consumed, and do not involve combustion or smoking.

A number of public health experts agree that risk-related communication is necessary to help adult smokers switch to less harmful alternatives. For example, Cancer Research in the UK has advised that “[u]nderstanding and communicating the benefits of nicotine replacements, such as e-cigarettes, is an important step towards reducing the number of tobacco-related deaths here in the UK.”[10] Kiviniemi and Kozlowski make the point more forcefully:

Given the scientific consensus that cigarettes are the most deadly form of tobacco use, the public has a right to a clear understanding of this fact and efforts should be made to impart an understanding of the differential health risks for various tobacco/nicotine products.[11] 

Indeed, in the absence of factual information about the relative risks of different tobacco and nicotine products, smokers are likely to be misled into believing that all products present the same level of risk and will continue smoking. In February 2018, Public Health England issued a report on e-cigarettes and heated tobacco products. Among other findings, the report highlights the inaccurate reporting of scientific studies by the media. After giving examples of headlines that do not reflect the facts, the report observed that “[t]he consequences of this inaccurate or inadequate reporting are that the general public is misled. This could induce smokers to carry on smoking rather than switching.”[12]

By applying different regulations to smoke-free products, governments can signal to consumers that smoke-free products and cigarettes differ in their risk profile and that, should adults make an informed decision to use nicotine, one product is better than another.

However, youth should not have access to any tobacco or nicotine-containing products. Directly selling or indirectly providing smoke-free products to youth should be prohibited and subject to rigorous enforcement. Restrictions on communications that could expose youth to smoke-free product advertising should apply, including bans on advertising in broadcast media (e.g., television and radio). However, those restrictions should not prevent adult smokers from getting the information they need to make better decisions for their health.

 

Several countries are already adopting differentiated regulations for smoke-free products

A number of governments around the world that recognize the potential of smoke-free products are taking steps to ensure that they are regulated differently from combustible products like cigarettes. For example, in July 2017, the U.S. Food and Drug Administration (FDA) announced a new approach to regulating the harms of combustible tobacco by increasing restrictions on cigarettes and by allowing “greater flexibility” for noncombustible products. According to former FDA Commissioner Scott Gottlieb:

Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts.[13]

The U.S. FDA’s approach is exemplified by its recent authorization of a heated tobacco product, and its characterization of the product as a “noncombusted cigarette”.[14]

In the European Union, the Tobacco Products Directive (TPD) acknowledges differences between tobacco and nicotine products by providing different definitions and regulations for “tobacco products for smoking” and “smokeless tobacco products”, which include “novel tobacco products” and “electronic cigarettes.”[15] For example, the TPD requires different health warnings for different types of tobacco and nicotine products. E-cigarettes must carry one of two warnings: “This product contains nicotine which is a highly addictive substance. It is not recommended for use by non- smokers.”, or “This product contains nicotine which is a highly addictive substance.” Heated tobacco products are categorized as novel smokeless products in the EU and also require their own separate warning: “This tobacco product damages your health and is addictive.”[16] These warnings differ significantly from those applicable to cigarettes, which are larger in size, include graphic images, and refer to the dangers of smoking and smoking-related diseases.[17]

The UK government has also recognized the need to regulate smoke-free products differently than cigarettes. In 2018, the UK House of Commons Science and Technology Committee published its report on e-cigarettes and heated tobacco. Among the report’s policy recommendations is that “[t]here should be a shift to a more risk-proportionate regulatory environment; where regulations, advertising rules and tax duties reflect the evidence of the relative harms of the various e-cigarettes and tobacco products available.[18] Indeed, regulations in the UK differentiate between different types of nicotine-containing products. For example, cigarettes are subject to a total advertising ban, including a ban on product display at retail. Cigarettes must also be sold in plain packaging, eliminating even the package as a potential communication channel with consumers. In contrast, e-cigarettes are not subject to a display ban or plain packaging and may be communicated on billboards and at the point of sale.[19]

Similarly, in Canada, regulations prohibit almost all consumer communications regarding cigarettes, prohibit product display and will soon require plain packaging, but allow greater communication ability for e-cigarettes. As Health Canada explains, this regulatory approach “provides a balance between protection of youth from nicotine addiction and tobacco use, and allowing adults to legally access vaping products as a less harmful alternative to cigarettes.”[20]

Finally, in New Zealand, the Ministry of Health announced in 2018 its plans to develop a new regulatory framework for smoke-free products, with “risk-proportionate regulation” as its cornerstone.[21]

 

Why switching completely to IQOS is less harmful than continued cigarette smoking.

General findings:

PMI has conducted a rigorous scientific assessment of IQOS incorporating elements of multiple disciplines, including aerosol chemistry and physics, in vitro, in vivo and systems toxicology, clinical studies, as well as pre-and post-market assessments of consumer perception, behavior, and actual use of IQOS. Our findings to date demonstrate that:

  • IQOS generates no combustion and no smoke.
  • IQOS generates an aerosol with, on average, 90-95% lower levels of toxicants than cigarette smoke and no solid carbon-based nanoparticles. The carbon-based nanoparticles in cigarette smoke are a hallmark of combustion and have been shown to trigger inflammation and demonstrated to cause lung cancer and cardiovascular disease. IQOS aerosol contains nicotine at similar levels as cigarette smoke.
  • Laboratory studies confirm that these lower levels of toxicants result in the aerosol generated by IQOS being significantly less toxic than cigarette smoke.
  • Clinical studies to date confirm the results of laboratory studies.
    • In two five-day and three-month clinical studies, the data show a significant reduction in the levels of exposure to 15 toxicants. Switching completely to IQOS achieves almost 95% of the overall reduction in exposure achieved by smoking abstinence, where smoking abstinence is the maximum achievable reduction in exposure.
    • Our most recent clinical study, measuring the biological response of people who switch to IQOS for six months compared with continued smoking showed improvements in all eight measures of biological response, with statistical significance in five of the eight. These results show that switching to IQOS is likely to reduce the risks of smoking-related disease as the product is actually used by people.
  • IQOS aerosol does not negatively impact indoor air quality.
  • Interest in IQOS among never-smokers and former smokers is low.

The totality of our evidence supports the conclusion that switching completely to IQOS is less harmful than continued cigarette smoking.[22]

So far, over 25 independent studies and review of IQOS validate different elements of our assessment approach or otherwise reach positive conclusions. Many of these agree that HTPs are a better choice than continuing to smoke cigarette. For example:

  • Public Health England: “The available evidence suggests that heated tobacco products may be considerably less harmful than tobacco cigarettes and more harmful than EC.”[23]
  • Committee on Toxicity: “[I]t is likely that there is a reduction in risk, though not to zero, to health for smokers who switch completely to heat-not-burn tobacco products.”[24]
  • The German Federal Institute for Risk Assessment (BfR): “Levels of major carcinogens are markedly reduced in the emissions of the analyzed [heat not burn] product in relation to the conventional tobacco cigarettes and that monitoring these emissions using standardized machine smoking procedures generates reliable and reproducible data which provide a useful basis to assess exposure and human health risks.”[25]

On April 30, 2019, the U.S. Food and Drug Administration (FDA) issued a Premarket Tobacco Product Application (PMTA) marketing order for IQOS and three HeatStick variants. The decision allows PM USA to commercialize IQOS in the U.S. As required by U.S. law, FDA reviewed extensive evidence and determined that introducing IQOS into the U.S. market is appropriate for the protection of the public health. In reaching this conclusion, FDA considered evidence about IQOS’s risk profile compared to cigarettes; evidence of the likelihood that current smokers who will not quit will switch completely to IQOS, evidence that unintended consumer groups, such as never-smokers, former smokers, and smokers who would otherwise quit are unlikely to use IQOS.

In addition, in the U.S. Food and Drug Administration’s press release announcing the marketing order authorizing IQOS for sale in the U.S., FDA states:

  • “Following a rigorous science-based review through the premarket tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the U.S. market is appropriate for the protection of public health, because, among several key considerations, the products produce fewer or lower levels of toxins than combustible cigarettes. […] In particular, through FDA's scientific evaluation of the company's applications, peer-reviewed published literature and other sources, the agency found that the aerosol produced by the IQOS Tobacco Heating System contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke. For example, the carbon monoxide exposure from IQOS aerosol is comparable to environmental exposure, and levels of acrolein and formaldehyde are 89% to 95% and 66% to 91% lower than from combustible cigarettes, respectively.”[26]
  • Further, the PMTA Technical Project Lead Review (TPL) notes: “Although the studies conducted by the applicant do not demonstrate reduction in long-term disease risks, the currently available evidence indicates CC [cigarette] smokers who switch completely to IQOS will have reduced toxic exposures and this is likely to lead to less risk of tobacco-related diseases."[27]

More particularly on emissions:

Nicotine-free dry particulate matter (NFDPM), commonly referred to as ‘tar’ is what is left when water and nicotine have been subtracted from cigarette smoke.[28] Heated tobacco products, such as IQOS, produce an aerosol, which is fundamentally different than cigarette smoke. Unlike cigarette smoke, which contains 50% water and glycerin, the IQOS aerosol contains 90% water and glycerin with on average 90% fewer harmful and potentially harmful constituents (HPHCs) and no carbon-based nanoparticles.[29] As such, even though it’s possible to calculate a NFDPM value for IQOS aerosol, the fundamental differences between IQOS aerosol and cigarette smoker render such a comparison meaningless and misleading. IQOS aerosol, therefore, does not produce ‘tar’ as known in the context of combustible cigarettes. Researchers from the German Federal Institute for Risk Assessment (BfR) made this point in a study on IQOS: “Although the NFDPM value for HNB products can be formally calculated as for the conventional cigarettes, direct comparisons would be misleading.”[30]

The IQOS aerosol contains 90 to 95% lower levels of harmful and potentially harmful constituents compared to the mainstream smoke of a standard reference cigarette.[31] Carbon monoxide (CO) is reduced by over 97%.[32]

Nicotine is an organic, naturally occurring compound found in the tobacco plant. As such, it is naturally present in the tobacco used in HEETS. Experts agree that nicotine is not the primary cause of smoking-related disease but the high levels of toxicants in the smoke of a burning cigarette.[33]

Further, nicotine content and delivery is an important element of product acceptance for adult smokers.[34] In addition to reducing health risks, in order to benefit public health, less risky alternatives need to be acceptable to adult smokers who will not quit in order to encourage them to switch completely. Many factors affect product acceptance, including taste, ritual, sensory experience, and nicotine delivery. Without an acceptable level of nicotine, smokers would not switch and would continue to smoke cigarettes – by far the most risky form of nicotine delivery.[35]

While nicotine is relatively safe, it is addictive and not risk-free. For this reason, certain people – minors, pregnant or breast-feeding women and people with heart disease, severe high blood pressure or diabetes – should not use tobacco or nicotine-containing products.

Article 19 of the European Union Tobacco Products Directive (EU TPD)[36] created a separate regulatory category for novel tobacco products that do not fall within the existing tobacco product categories as defined in Article 2. Furthermore, the regulatory requirements for novel tobacco products differ depending on whether the product is considered to be a product for smoking or smokeless, with the key differentiator being the presence or absence of combustion. For example, health warnings for smokeless novel tobacco products are not as large as those applied to smoked products and the warning message is more consistent with the known risks of the products.

On this basis, the proposed textual warning “This tobacco product contains tar, nicotine, carbon monoxide and other harmful substances, which seriously harm health and are addictive.” is inaccurate and misleading. Following its scientific review and conclusion that IQOS aerosol contains carbon monoxide at low levels comparable to environmental exposure, the U.S. FDA determined that a carbon monoxide related health warning, which under the US law would otherwise be applicable to HEETS tobacco sticks used with IQOS, will not be mandated for this product as it would be inaccurate and misleading.

“Use of Marlboro, Smooth Menthol Heatsticks, and Fresh Menthol Heatsticks in the IQOS device does not pose any CO-related risks. Accordingly, the required CO warning is misleading with respect to IQOS products. This warning should not be required on IQOS packaging or advertising.”[37]

For the reasons above, ewe propose to keep the current health warning for smokeless tobacco products since this is accurate and helps the adult smokers to appropriately understand that the risk profile of smokeless tobacco products is different compared to cigarettes and other smoking tobacco.

And on the levels of HPHCs in the IQOS aerosol and the tobacco used in HEETS:

The U.S. Food and Drug Administration tested the levels of HPHCs in the IQOS aerosol and the tobacco used in HEETS. It validated the results of PMI’s assessment showing substantial reductions in the levels of HPHCs relative to cigarette smoke for the HPHCs it tested, and accepted PMI’s assessment for the remainder of HPHCs reported by PMI:

  • “Preliminary assessment of the data indicates that the levels of acrolein, formaldehyde, and benzo[a]pyrene in the IQOS aerosol measured by STL [FDA’s Southeast Tobacco Laboratory] are higher than the values reported by the applicant; however, these three HPHCs are still significantly lower than the levels in the mainstream smoke of the reference cigarette 3R4F. Greater than 90% reduction was observed for acrolein and benzo[a]pyrene, and greater than 80% reduction was observed for formaldehyde in the aerosol compared to 3R4F. The levels of tar and nicotine determined by STL were similar to the levels reported by the applicant. Finally, the levels of ammonia, NNN, and NNK in the HeatSticks tobacco filler measured by STL were similar to the levels reported by the applicant. […] As summarized above, all the 54 measured HPHCs produced by the three HeatSticks were substantially reduced compared to the 3R4F cigarette on a per-cigarette basis.”[38]

Further, the PMTA Technical Project Lead Review (TPL) notes: “Although the studies conducted by the applicant do not demonstrate reduction in long-term disease risks, the currently available evidence indicates CC smokers who switch completely to IQOS will have reduced toxic exposures and this is likely to lead to less risk of tobacco-related diseases."[39] 

Finally, the FDA marketing order for IQOS sets out clear commercialization guidelines, including marketing requirements, that maximize the opportunity for adults to switch from cigarettes, while minimizing unintended use. We fully support this objective and continuously strive to ensure that our smoke-free alternatives including IQOS is reaching the right audience—current adult smokers.

 

Moldova could continue to be a leader in public health

Moldavian law on tobacco control in its current state addresses the need for a different regulatory framework for smoke-free products. The Law also provides adult smokers access to accurate and non-misleading information, allowing them to be aware of the distinctive risk profiles that characterize the different categories of tobacco and nicotine products in order for them to make an informed choice.  Since the launch of IQOS and HEETS in Moldova in [July of 2018] [20 000of adult smokers] have already left behind the most harmful nicotine delivery – the cigarette – and switched to a smoke-free alternative, showing a first step towards the trend in reduction of smokers outlined in a recent study in Japan. Researchers from the American Cancer Society examined whether the introduction of IQOS had reduced per capita cigarette sales in Japan. They conclude:

“The example of IQOS in Japan demonstrates a circumstance in which cigarette consumption has likely been reduced via the introduction of an alternative non-combustible tobacco product.”[40]

 The Proposal which equalizes the regulation for smoke-free and combustible tobacco products jeopardizes the switching from cigarettes to smoke-free products and is therefore a step in the wrong direction for the protection of public health in Moldova.

Conclusion

The current regulatory framework in Moldova provides adequate differentiation between the most harmful way of nicotine delivery – smoking tobacco – and the less harmful smoke-free alternatives such as heated tobacco products. We hope that our comments above are helpful in order for the Government and the Parliament of the Republic of Moldova to re-assess the draft Law No. 52 dated of May 31st , 2019 and realize that the Proposal is a step backwards for the protection of public health in Moldova.

 

 

 

 

 

 

[1] See Guidelines for Implementation of Article 5.3, available at https://www.who.int/fctc/guidelines/article_5_3.pdf

[2] See Guidelines for Implementation of Article 5.3, paragraph 20, recommendation 2.2, available at https://www.who.int/fctc/guidelines/article_5_3.pdf

[3]  See official letter by the European Commission Secretariat-General dated 7 February 2013.

[4] See Clive Bates and David Sweanor, Rational tobacco and nicotine policy in Brazil: response to ANVISA Public Consultation No. 314, April 2017, available at https://www.clivebates.com/documents/BrazilResponseApril17.pdf. 

[5] Abrams, et al. Statement from specialists in nicotine science and public health policy to Dr. Margaret Chan, WHO Director General, May 2014, available at https://nicotinepolicy.net/documents/letters/MargaretChan.pdf.   

[6] Abrams, D.B., et al., Managing nicotine without smoke to save lives now: Evidence for harm minimization, Journal of Preventative Medicine, 2018, available at https://www.sciencedirect.com/science/article/pii/S0091743518301981.  

[7] Clive Bates, Consultation submission to Australian Parliament on use and marketing of e-cigarettes, July 2017, available at https://www.clivebates.com/papers/.

[8] Association Quebecoise Des Vapoteries v. La Procureure Generale Du Quebec, 2019 QCCS 1644 (Superior Court), Para. 371, May 3, 2019 (English translation), original decision in French available at http://citoyens.soquij.qc.ca/php/decision.php?ID=78D52A8DF0724D993892EB66867FC9EB&captchaToken=03AOLTBLQNx1gU8FAFvZURIGko32vkCS0NftWyMPJ2lPy-Vnh9_vRAWwAfq11ApDFXFVDvvTLnsHnbzzPnvlc5LcbPcdwdfcvw6567kNkfiaUijZT73caVkNX_5CSA59d2ei1M6vm_Y32sUopF3bxzC2cmQv3TwDQGR600yDsMEefceV7xHX8O6Pf9GPKdzx9OZNy6Qv7gF_kJSqttcQCtkMaOTetLNr1S9ldBKb7n0AEDSz4Q0SrH95mpZWAEWp8vn2zt1JIKdvSyV-cOVqCsJFKW6h9KMqvRgX-ItXGCzZcCuZep3jNq3gFli13FiHBpDjz7F6i6BCVBHgxpIjGhJmU2BdvuwJkmGA.

[9] Id. at paras. 319-20, 326.

[10] Cancer Research UK, E-cigarettes safer than smoking says long-term study (quoting Alison Cox, director of cancer prevention at Cancer Research UK), February 7, 2017, available at http://www.cancerresearchuk.org/about-us/cancer-news/press-release/2017-02-06-e-cigarettes-safer-than-smoking-says-long-term-study.

[11] Kiviniemi, M. & Kozlowski, L., Deficiencies in Public Understanding About Tobacco Harm Reduction: Results from a United States National Survey, 12 Harm Reduction Journal 1, 2 (2015), available at https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-015-0055-0.

[12] Public Health England, Evidence review of e-cigarettes and heated tobacco products 2018 (2018), available at https://www.gov.uk/government/publications/e-cigarettes-and-heated-tobacco-products-evidence-review.

[13] US Food and Drug Administration, Health Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap, January 2018, available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm591993.htm.

[14] U.S. FDA, FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway, April 30, 2019, available at https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway.

[15] EU TPD 2014/40/EU, April 2014, available at https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf.

[16] Id.

[17] Id.

[18] UK House of Commons, Science and Technology Committee, E-cigarettes, Seventh Report of Session 2017-19, available at https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/505/505.pdf.

[19] UK Department of Health, Guidance on Article 20(5), tobacco products directive: restrictions on advertising electronic cigarettes, May 2016, available at https://www.gov.uk/government/publications/proposals-for-uk-law-on-the-advertising-of-e-cigarettes/publishing-20-may-not-yet-complete.

[20] Health Canada, New Tobacco and Vaping Products Legislation Receives Royal Assent, May 28, 2018, available at https://www.canada.ca/en/health-canada/news/2018/05/new-tobacco-and-vaping-products-legislation-receives-royal-assent.html.

[21] New Zealand Ministry of Health, Ministry to consider risk-proportionate regulation for vaping and heated tobacco products, May 2018, available at https://www.health.govt.nz/news-media/news-items/ministry-consider-risk-proportionate-regulation-vaping-and-heated-tobacco-products.

[22] Philip Morris Products S.A., Tobacco Heating System (IQOS) Briefing Document, December 2017, available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM593108.pdf.

[23] Public Health England, E-cigarettes and heated tobacco products: evidence review, available at https://www.gov.uk/government/publications/e-cigarettes-and-heated-tobacco-products-evidence-review

[24] UK Committee for Toxicology, Statement on heat not burn tobacco products, available at https://cot.food.gov.uk/sites/default/files/heat_not_burn_tobacco_summary.pdf

[25] The German Federal Institute for Risk Assessment (BfR), Levels of selected analytes in the emissions of “heat not burn” tobacco products that are relevant to assess human health risks, available at https://link.springer.com/article/10.1007%2Fs00204-018-2215-y

[26] FDA, press release, 30 April 2019, available at https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway

[27] FDA, PMTA Technical Project Lead Review (TPL), page 11, available at https://www.fda.gov/media/124247/download

[28] See DIRECTIVE 2014/40/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 April 2014, https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf.

[29] Id. (stating The carbon-based nanoparticles in cigarette smoke are the hallmark of combustion and have been known to trigger inflammation and demonstrated to cause lung cancer and cardiovascular disease.”)

[30] The German Federal Institute for Risk Assessment (BfR), Levels of selected analytes in the emissions of “heat not burn” tobacco products that are relevant to assess human health risks, available at https://link.springer.com/article/10.1007%2Fs00204-018-2215-y

[31] Jaccard, G., et al. (2017). Comparative assessment of HPHCs yields in the Tobacco Heating System THS2.2 and commercial cigarettes. Regul Toxicol. Pharm., 90: 1-8.  

[32] PMI’s Executive Summary of its Modified Risk Tobacco Product (MRTP) Application for IQOS system and three types of Heatstick products to the United States Food and Drug Administration, 24 May 2017, available at https://www.fda.gov/tobacco-products/advertising-and-promotion/philip-morris-products-sa-modified-risk-tobacco-product-mrtp-applications#E

[33] See e.g., Truth Initiative, Re-thinking nicotine and its effects, 2016, https://truthinitiative.org/sites/default/files/ReThinking-Nicotine.pdf; U.S. Food and Drug Administration, Healthy innovation, safer families: FDA’s strategic policy roadmap, January 2018, https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf

[34] See FDA, FDA permits sale of IQOS Tobacco Heating System through pre-market tobacco product application pathway, 30 April 2019, available at https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway (stating “Additionally, IQOS deliver nicotine in levels close to combustible cigarettes suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes and use IQOS exclusively).”

[35] See U.K. House of Commons, Science and Technology Committee, E-cigarettes, July 2018, available at https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/505/505.pdf.

[36] See DIRECTIVE 2014/40/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 April 2014, https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf.

[37] FDA, PMTA Technical Project Lead Review (TPL), page 89, available at https://www.fda.gov/media/124247/download

[38]FDA Briefing document, page 13, available at https://www.fda.gov/media/110387/download

[39] FDA, PMTA Technical Project Lead Review (TPL), page 11, available at https://www.fda.gov/media/124247/download

[40] Effect of IQOS introduction on cigarette sales: evidence of decline and replacement, Michal Stoklosa, Zachary Cahn, Alex Liber, Nigar Nargis, Jeffrey Dope, Tobacco Control – 17 June 2019, available at https://tobaccocontrol.bmj.com/content/early/2019/06/11/tobaccocontrol-2019-054998